Scalence L.L.C. · 18 hours ago
Quality Systems Specialist
Exton, PA
Full-time
Hybrid
Mid Level
$45/hr - $48/hr
3+ years expScalence L.L.C. is a company specializing in quality systems within the pharmaceuticals sector, and they are seeking a Quality Systems Specialist. The role involves performing quality systems activities, developing SOPs, and supporting project management to ensure compliance and improve quality outcomes.
Information Technology & Services
Responsibilities
Perform core regional quality systems activities as assigned (e.g., revising procedures; assisting in inspection readiness) following defined procedures
Develop, improve, and revise regional quality system SOPs
Conduct ongoing analysis and reporting of key quality and risk metrics and required actions
Monitor and identify gaps within quality systems area and escalate for appropriate action
Support project management for programs/ projects within quality systems area, and communicate with cross-functional teams within site/ area to drive quality outcomes
Qualification
Required
Prior cGMP experience is a must have
Ideal candidate will have 3-5 years' experience
Must have QUALITY experience
Bachelor's degree, preferably in chemistry, biochemistry, or equivalent technical discipline with 3+ years of experience relevant to role (e.g. auditing and regulatory inspections; learning management systems/ training operations; document control processes; electronic quality systems)
Experience in compliance with cGMPs and relevant health authority and regional guidelines
Experience in execution of quality processes within own quality systems area (e.g., SOP and protocol writing, metrics monitoring), and assisting in resolution of issues
Proven performance in earlier role
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase